Osypka Medtec Inc. · 1 day ago
Design Quality / Assurance Manager
Legal Address - Longmont, CO 80504
Full-time
Onsite
Lead/Staff, Director/Executive
$109K/yr - $150K/yr
5+ years expOsypka Medtec Inc. is a leading contract design and manufacturing medical device company. They are seeking a Design Quality/Assurance Manager to ensure products meet regulatory and quality standards while leading the quality team in design quality assurance and continuous improvement efforts.
Medical Device
Responsibilities
Lead and develop the quality team personnel including: quality engineers, quality specialists, and quality control inspectors
Oversee the development and implementation of quality control procedures for manufacturing processes
Drive continuous improvement efforts to enhance the quality and efficiency of operations
Ensure timely and effective resolution of quality issues by driving investigations of nonconformances (NCRs), deviations, and out-of-tolerance (OOT) results; collaborate with cross-functional teams on root cause analysis and corrective and preventive actions (CAPA)
Provide leadership, training, and development to team members to maintain a high-performing team
Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle
Prepare and present quality reports to senior management and regulatory agencies as required
Qualification
Required
Bachelor's or Master's degree in engineering or a related field
Minimum of 5 years experience in quality management in the medical device industry
Minimum of 5 years experience managing a team
In-depth knowledge of medical device regulations, including FDA 21 CFR 820 and ISO 13485:2016
Experience with Class II/III medical device development and manufacturing is strongly preferred
Working knowledge of statistical process control, design control, and other quality tools
Excellent problem-solving and analytical skills
Strong communication and team collaboration skills
Ability to work in a fast-pace and dynamic environment
Company
Osypka Medtec Inc.
Located in Longmont, Colorado, Osypka Medtec is an Original Equipment Manufacturer (OEM) and is dedicated to working with medial device manufacturers and suppliers to manufacture innovative, quality product solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Dana Tompkins
Chief Executive Officer (CEO)
Company data provided by crunchbase